Kornimate/medical-research-clean huggingface dataset:
evaluation of a probiotic on ldl-cholesterol levels

Conditions: Cardiovascular Diseases; LDL-cholesterol

Summary: the aim of the present study is to evaluate the ability of bifidobacterium bsl_ps404 in reducing ldl-cholesterol levels in healthy individuals.

there is a strong correlation between ldl-cholesterol and cardiovascular diseases. conjugated bile acids help to break down and emulsify dietary fat into micelles that promote their absorption by the enterocytes. the disruption or alteration of these micelles may interfere with the absorption of cholesterol. several intestinal bacteria strains are capable of carrying out numerous biotransformations of bile salts during their enterohepatic circulation, such as the hydrolysis of the conjugated bile acids by the action of hydrolases. the mechanism proposed to explain the cholesterol-lowering activity of these probiotic strains is that, due to the greater bile salt hydroxylation in the intestine, the formation of micelles would decrease and, therefore, the absorption of cholesterol and lipids would be decrease too. in addition, probiotics may also increase the excretion of bile acids in the stool, possibly by binding or absorbing them. this increase in fecal secretion of bile acids would require an increase in the hepatic catabolism of cholesterol for the synthesis of bile acids. all these processes may help to reduce ldl-cholesterol levels bifidobacterium bsl_ps404 is a bacterium isolated from maternal milk with qps category that presents a high hydrolase activity that exceeds in more than 20% the activity of other reference strains.

Eligibility criteria:
inclusion criteria: * levels of ldl-cholesterol between 100 and 190 mg/dl. * accept freely to participate in the study and sign the informed consent document. exclusion criteria: * be pregnant. * have planned to carry out a dietary intervention or exercise practice with the aim of losing weight in the coming weeks. * having a serious illness. * having diabetes. * having a cerebrovascular disease. * being allergic to any group of antibiotics. * take probiotics in the form of supplements at least 4 weeks before. * take antibiotics at least 4 weeks before. * being taking products or drugs to control cholesterol levels

Keywords: ldl-cholesterol probiotics
i-gel in out-of-hospital cardiac arrest in norway

Conditions: Out of Hospital Cardiac Arrest

Summary: the main objective of this trial is to compare the effectiveness of a newer supraglottic airway method (the i-gel), compared to current airway management practice in out-of-hospital cardiac arrests treated by norwegian ambulance services.


Eligibility criteria:
inclusion criteria: * out-of-hospital cardiac arrest patients requiring and receiving advanced airway management on ambulance missions. advanced airway management is defined as the attempted insertion of an airway adjunct (i-gel, laryngeal tube or eti) or the administration of ventilatory assistance/support (including bag-mask ventilation (bmv) or other ventilatory support. * adult patients (\> 18 years). exclusion criteria: * non-adult patients / minors (\< 18 years). * traumatic cardiac arrest.
an efficacy and safety trial of serostim® in the maintenance of the treatment effect obtained during the study of serostim® in human immunodeficiency virus-associated adipose redistribution syndrome

Conditions: Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS); Human Immunodeficiency Virus Infections

Summary: this is an open-label, multi-center, randomized, parallel-group, maintenance trial of serostim® in subjects who have completed a prior serostim® human immunodeficiency virus-associated adipose redistribution syndrome (hars) trial (study 22388). the subjects, who encountered toxicity during the antecedent protocol, will be assigned to a 1 milligram (mg) dose. all other subjects will be randomized in 1:1 ratio, to receive up to 2 mg or 4 mg of serostim®, beginning from day 1 of week 1. doses will be adjusted downward in subjects weighing less than 55 kilogram (kg). serostim® therapy will be continued at the assigned doses through week 12 (period 1). subjects, who will encounter toxicity during period 1, will be assigned to the 1 mg group for period 2. all other subjects will be randomized in a 1:1 ratio to receive up to 2 mg or 1 mg of serostim® on a weight adjusted basis. period 2 therapy will begin on day 1 of week 13, continuing through week 36. study visits are required at screening (that is, final visit of the antecedent trial), day 1 of week 1 (baseline), and at weeks 2, 6, 12, 14, 24, 30 and 36.


Eligibility criteria:
inclusion criteria: * complete all treatments prescribed by the antecedent protocol (study 22388) * be able and willing to comply with the protocol for the duration of the study, including concomitant therapy restrictions * have given written informed consent * if female, be post-menopausal, surgically sterile, or using adequate contraception exclusion criteria: * experienced a protocol defined toxicity or any other adverse event, which caused premature withdrawal from the antecedent study (study 22388) * withdrew from the antecedent study or was discontinued prematurely for any other reason * based on the final visit evaluations from the antecedent trial, would be required to withdraw from the antecedent protocol, if (theoretically) the antecedent trial continued beyond the final visit * based on the final visit evaluations from the antecedent trial, would be required to temporarily stop or reduce the dose of study drug, if (theoretically) the antecedent trial continued beyond the final visit. this does not apply to subjects whose study drug was temporarily stopped or whose study drug dose was reduced prior to the final visit (screening), provided they continued in the antecedent protocol and are stable at the time of the final visit (screening)

Keywords: human immunodeficiency virus-associated adipose redistribution syndrome (hars) human immunodeficiency virus infections serostim® recombinant human growth hormone (r-hgh)
accuracy of a cad/cam surgical template for mandible distraction

Conditions: Facial Asymmetry; Mandible; Hypoplasia, Unilateral Condylar; Distraction of Bone

Summary: the purpose was to assess the accuracy and clinical validation of virtual planning and surgical template in mandible distraction osteogenesis. patients with hemifacial microsomia were enrolled. virtual planning and simulation were performed on three-dimensional models. distraction was simulated on virtual model and the new morphology of the mandible was predicted. the position and direction of the distractor was determined to achieve the optimal morphology. the templates were designed based on virtual planning and manufactured using three-dimensional printing technique. the template is designed to assist the surgeon to perform the osteotomy and predrill the screw holes to guide the distractor position. the outcome evaluation was completed by comparing planned outcomes with postoperative outcomes. linear and angular differences for the distractor was measured.


Eligibility criteria:
inclusion criteria: * patients who were scheduled to undergo mandibular do via intraoral approach * patients who were scheduled to undergo ct scan as a part of their diagnosis and treatment * patients who agreed to participate in this study exclusion criteria: * patients requiring more than one distractor of the mandible * patients with mandible defect * patients with previous mandibular trauma
ear drops for children with otitis media

Conditions: Acute Otitis Media

Summary: the purpose of this study is to determine if a commercially available homeopathic ear drop preparation is effective in reducing symptoms in children 6 months - 11 years old with acute otitis media. a total of 120 study patients with otitis media will be randomized to receive homeopathic ear drops, or no ear drops, in addition to receiving standard care. it is postulated that children using the ear drops will have more rapid resolution of symptoms and need fewer antibiotics than those randomized to not receive the ear drops.


Eligibility criteria:
inclusion criteria: * presenting to participating clinic with otitis media * diagnosed with acute otitis media * parents rate symptoms as a "moderate problem" or more exclusion criteria: * diagnosis of otitis media within preceding 30 days * receipt of antibiotics within 2 days * perforated ear drum or bullous lesion * receipt of homeopathic treatment within 30 days

Keywords: otitis media children
comparative evaluation of stroke triage algorithms for emergency medical dispatchers

Conditions: Stroke

Summary: this study will compare the diagnostic accuracy of card 28 stroke protocol to card 28 and cincinnati stroke scale, when used by emergency medical dispatchers to interrogate a 911 call suggestive of stroke. the authors hypothesize that a combination of card 28 plus the cincinnati stroke scale (css) will improve the diagnostic accuracy of emergency medical dispatchers for stroke.


Eligibility criteria:
inclusion criteria: 1. all 911 calls transferred by local public service answering points (psaps) to the county communication center of santa clara county where the emergency medical dispatchers complete the interrogation using mpds protocols. 2. all 911 calls received directly at the county communication center of santa clara county where emergency medical dispatchers complete the interrogation using the mpds protocols. 3. all 911 calls received from subjects (patient) aged \> 18 years or second party calls (by-stander or family who are in close proximity to the patient and can administer the tool) by subjects \> 18 years of age. exclusion criteria: 1. all calls that require immediate response (echo level determinant for life threatening conditions) and emergency medical dispatchers cannot complete card 28 2. calls answered by emergency medical dispatchers who have not completed training on the use of cincinnati stroke scale. 3. calls originating from the cities of palo alto, mountain view, sunnyvale, santa clara, and san jose that are not interrogated by the county communication center for santa clara county. 4. 911 calls with no available outcomes in the final discharge database. -

Keywords: cerebrovascular accident stroke,acute
speech performance and clinic efficiency with remote care compared with standard of care in adults with a cochlear implant in the first 12 months post-activation

Conditions: Hearing Loss

Summary: the aim of the study is to assess the real-world effectiveness of managing participants within the first year post-activation (between 3 and 12 months) using cochlear's remote care (remote check and remote assist), as compared with standard in-clinic management. the study captures also the time and costs associated with both models of care to quantify the potential costs savings and efficiency gains possible with delivering cochlear implant (ci) aftercare remotely.


Eligibility criteria:
inclusion criteria: * aged 18 years or older (no upper age limit) * post-lingually deafened or pre-lingually deafened with measurable word scores in quiet using a cochlear implant * unilaterally implanted with a compatible cochlear™ implant * currently using a compatible cochlear™ sound processor * 3 months, +/- 2 weeks, experience with a cochlear implant (post-activation) at the time of baseline measurements * direct access to a compatible smart phone * fluent in the languages used for the study, as determined by the investigator * willing to participate in and comply with all requirements of the protocol, including willingness to be randomised to either arm * willing and able to provide written informed consent exclusion criteria: * patient has a map incompatible with master volume, bass and treble (mvbt) programming: * non-monopolar maps (bipolar, common ground, variable mode) * dynamic range of \<10 comfortable level (cl) * hybrid mode enabled * pulse widths \>100 µs * 10 or more electrodes turned off * patient has on-going fluctuations in map threshold levels (ts) and comfort levels (cs) and/or impedances * patient requires frequent individual channel measurements and/or measurements without the use of live-stimulation * score below 3 on the screening subset of questions from the mobile device proficiency questionnaire (mdpq) * abnormal cochlea anatomy and/or facial nerve stimulation that requires complex or more frequent programming, as determined by the investigator * additional disabilities that would prevent participation in evaluations, including significant visual impairment and/or dexterity issues * unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator * investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling * cochlear employees or employees of contract research organisations or contractors engaged by cochlear for the purposes of this investigation * current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a cochlear sponsored investigation and determined by the investigator or sponsor to not impact this investigation).

Keywords: cochlear implant aftercare remote clinical management
coronary microvascular dysfunction assessments in myocardial infarction with non-obstructive coronary arteries

Conditions: Myocardial Infarction; Coronary Microvascular Dysfunction; Vasospasm, Coronary

Summary: to compare clinical outcomes of myocardial infarction with non-obstructive coronary arteries (minoca) according to the coronary microvascular dysfunction (cmd), evaluated by optical coherence tomography (oct), invasive and non-invasive coronary physiologic assessment.

background approximately 5\~10% of patients with acute myocardial infarction (ami) have been reported as myocardial infarction with non-obstructive coronary arteries (minoca) in the contemporary clinical setting. although those with minoca have a better prognosis than with obstructive coronary artery disease, several observational studies continuously reported that patients with minoca showed comparable outcomes. one plausible explanation of this discrepancy is the heterogeneous and variable definition of minoca. possible causes of minoca include plaque erosion and/or rupture, vasospasm, and cmd. therefore, it is natural that heterogeneous pathophysiology of minoca causes diagnostic challenges and proper management. recently, there have been efforts for establishing the diagnosis of minoca and standardizing the systematic management according to the cause of minoca. according to the aha scientific statement, patients who suspected minoca have been recommended to perform multimodality approach, including intravascular imaging (i.e., oct). although non-invasive methods, such as n-13 ammonia positron emission tomography (pet), can be used for evaluating the cmd, invasive coronary physiologic assessment using pressure-temperature wire has been recommended. cmd has been known as a major cause of minoca, and it may be required specific treatment. nevertheless, there has no data on the outcomes of minoca with or without cmd. therefore, the aim of cmd-minoca sought to assess the minoca patients regarding the latest clinical pathway for diagnosis of cmd and evaluate their clinical outcomes at 2 years.

Eligibility criteria:
inclusion criteria: * subject with age ≥19 years and acute myocardial infarction * rise and/or fall of cardiac troponin with one level \>99 percentile plus ischemic signs/symptoms * subject with non-obstructive coronary arteries * \<50% diameter stenosis or * fractional flow reserve (ffr) \>0.80 ③ subject without previous history of coronary artery disease * subject who performed invasive coronary angiography within 24 hours after presentation ⑤ subject who eligible for invasive and non-invasive coronary physiologic assessment exclusion criteria: * subject with obstructive coronary arteries * subject with alternate diagnosis including sepsis, pulmonary embolism, myocarditis, takotsubo syndrome, spontaneous coronary dissection, and other cardiomyopathies. * subject with cardiogenic shock or cardiac arrest ④ subject who has non-cardiac co-morbid conditions with life expectancy \<1 year ⑤ subject or lactating women ⑥ subject unable to provide consent

Keywords: minoca coronary physiology cardiac pet cfr imr oct
predicting response of metastatic triple negative breast cancer to immunotherapy based on patients cytokine profile

Conditions: Metastatic Triple-Negative Breast Cancer

Summary: recent progress in immunotherapy (it) has shifted treatment paradigms for multiple malignancies including breast cancer. it has been shown that levels of certain cytokines were correlated with increased response to immunotherapy in patients with metastatic breast cancer. in this study investigators will perform cytokine profiling among patients diagnosed with metastatic triple-negative breast cancer at different time points during the treatment.

this is a prospective study that has two groups of patients as determined by their prescribed treatment plan. group a (control group) are patients with metastatic triple-negative breast cancer (tnbc) who receive chemotherapy only (current standard of care). group b (experimental group) are patients with mtnbc who receive a combination of chemotherapy and it immunotherapy (atezolizumab) which is a standard of care for patients whose tumor express \>1% of pd-l1 molecules. t-cell cytokines will be measures prior to treatment and at multiple time points during the treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of metastatic triple negative breast cancer * 18 years of age or older exclusion criteria: * younger than 18 * unwilling to participate or unable to give informed consent

Keywords: cytokine, breast cancer
a phase i study to determine the safety and immunogenicity of the candidate influenza vaccine chadox1-np+m1

Conditions: Influenza

Summary: this is a first in man dose escalation study, to assess the safety and immunogenicity of the candidate influenza vaccine chadox1-np+m1. all volunteers recruited will be healthy adults aged 18-50. volunteers will be enrolled and doses will be escalated according to a "3+3" study plan. up to 24 volunteers will be vaccinated. following one dose of the vaccine, volunteers will be followed up to assess the side effect profile of the vaccine and to take blood tests. a series of immunology assays will be performed to determine how potent the vaccine is at inducing an immune response.


Eligibility criteria:
inclusion criteria: the volunteer must satisfy all the following criteria to be eligible for the study: * men and women aged 18-50 * resident in or near oxford for the duration of the vaccination study * able and willing (in the investigators' opinions) to comply with all study requirements * willing to allow the investigators to discuss the volunteer's medical history with their general practitioner * willingness to use effective contraception for 4 weeks from the date of vaccination * agreement to refrain from blood donation for 4 weeks from the date of vaccination * written informed consent exclusion criteria: the volunteer may not enter the study if any of the following apply: * participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period * previous receipt of any recombinant adenoviral vectored vaccine * previous receipt of mva-np+m1 * administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate * any confirmed or suspected immunosuppressive or immunodeficient state, including hiv infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled/topical steroids are allowed) * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine * any history of anaphylaxis in reaction to vaccination * history of cancer (except basal cell carcinoma and cervical carcinoma in situ) * history of serious psychiatric condition * any chronic illness requiring ongoing or awaiting hospital specialist supervision, other than minor surgical procedures and follow up of surgery over 6 months prior to screening. * suspected or known current injecting drug or alcohol abuse (as defined by an alcohol intake of greater than 42 units every week) * seropositive for hepatitis b surface (hbsag) or hepatitis c virus (antibodies to hcv) * pregnancy, lactation or willingness/intention to become pregnant during the study * any other significant disease, disorder or finding (including blood test results), which, in the opinion of the investigators, would either put the volunteer at risk because of participation in the study, or may influence the result of the study. * no response / confirmation from gp regarding previous medical history
post-exercise recovery of doms in recreational athletes

Conditions: Injury;Sports

Summary: the main goal of this study was to investigate the effectiveness of cryo-sauna in preventing the development of doms in the lower extremity. the second goal is to analyze the rate of regenerative changes in the right muscles after acute fatigue-induced exercises.

the main goal of this study was to investigate the effectiveness of cryo-sauna in preventing the development of doms in the lower extremity. the second goal is to analyze the rate of regenerative changes in the right muscles after acute fatigue-induced exercises. this study design was a randomized, controlled single-blind trial with repeated measures. moreover, the design was prepared according to the consolidated standards of reporting trials (consort) for pragmatic trials. participants were assigned into two groups: (1) experimental group (cryo, n =16) - cryostimulation using a cryo sauna; and (2) control group (cont, n = 15) - without any intervention. this study was conducted in the physical exercise laboratory. both groups, cryo and con performed a fatigue-induced protocol consisting of counter-movement jumps (cmj) (10 set for 10 repetitions). after the fatigue exercises, only cryo underwent cryo sauna intervention including entry immediately after, 24, 48, and 72 hours post-exercise. the order of measurements at baseline included: blood sample testing (creatine kinase, myoglobin, leukocytes) and muscle stiffness of the lower extremity. all measurements we collected at baseline, immediately post, 24, 48, 72, and 96 hours post-exercise.

Eligibility criteria:
inclusion criteria: * no previous experience with cryostimulation using a cryo-sauna, * recreational lifestyle. exclusion criteria: * current or prior pain or injury in the lower extremity. * previous history of surgery in the lower extremity. * cardiovascular disabilities.

Keywords: doms injury prevention performance muscle properties